ZELBORAF- vemurafenib tablet, film coated
ZELBORAF can cause serious side effects, including:
Risk of cancers. ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Talk with your healthcare provider about your risk for these cancers.
Check your skin and tell your healthcare provider right away about any skin changes including a:
Your healthcare provider should check your skin before you start taking ZELBORAF, and every 2 months while taking ZELBORAF, to look for any new skin cancers. Your healthcare provider may continue to check your skin for 6 months after you stop taking ZELBORAF.
Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF.
See "What are the possible side effects of ZELBORAF?" for more information about side effects.
What is ZELBORAF?
ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma,
Your healthcare provider will perform a test to make sure that ZELBORAF is right for you.
It is not known if ZELBORAF is safe and effective in children under 18 years of age.
What should I tell my healthcare provider before taking ZELBORAF?
Before you take ZELBORAF, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ZELBORAF?
What should I avoid while taking ZELBORAF?
Avoid sunlight while you are taking ZELBORAF. ZELBORAF can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:
ZELBORAF may cause serious side effects, including:
The most common side effects of ZELBORAF include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZELBORAF. For more information about side effects, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Genentech at 1-888-835-2555.
How should I store ZELBORAF?
Keep ZELBORAF and all medicine out of the reach of children.
General information about ZELBORAF
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZELBORAF for a condition for which it was not prescribed. Do not give ZELBORAF to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZELBORAF that is written for health professionals.
What are the ingredients in ZELBORAF?
Active ingredient: vemurafenib
Inactive ingredients: Tablet Core: hypromellose acetate succinate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose.
Coating: pinkish white: poly (vinyl alcohol), titanium dioxide, polyethylene glycol 3350, talc, and iron oxide red.
Distributed by: Genentech USA, Inc., A Member of the Roche Group,1 DNA Way, South San Francisco, CA 94080-4990
ZELBORAF is a registered trademark of Genentech, Inc
Co-promoted by: Genentech USA, Inc. and Daiichi Sankyo, Inc.
©2015 Genentech, Inc. For more information, go to www.ZELBORAF.com or call 1-877-436-3683.
This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: August 2015